Pharmaceutical Manufacturing
AI built for GMP environments that your QP and FDA can both sign off
You get AI agents for batch monitoring, quality control, deviation management, and regulatory documentation — validated to 21 CFR 211 and EU GMP Annex 22, running entirely on your cloud.
21 CFR 211 validated. EU GMP Annex 22 compliant. Your cloud. Your data.
Proof of concept
To measurable ROI
AWS, Azure or GCP
GMP compliance and AI are no longer separate conversations
The FDA's January 2025 AI guidance and the EU's new GMP Annex 22 have made one thing clear: AI systems that influence GMP decisions — batch release, QC, process control — must be validated, documented, and auditable to the same standard as your other controlled systems.
Most AI vendors do not understand GxP. We do. We design every AI workflow to your validation requirements before we build, so your quality team and your regulators see a system they can rely on — not a liability.
US GMP validation standard our agents are built to
new EU GMP AI standard published for consultation 2025
typical batch investigation time reduction with AI
on AI documentation for clients entering FDA PAI
From batch data to GMP-compliant output — in one workflow
We connect your MES, LIMS, ERP, and batch record systems to AI agents that monitor process parameters, detect deviations, accelerate investigations, and generate CAPA documentation — all validated, all auditable, all on your cloud
MES, LIMS, ERP and batch records
- Approval gates
- Human-in-loop
- Audit logging
AWS, Azure or GCP
- Batch records
- CAPA documentation
- Deviation reports
What we deliver for pharmaceutical manufacturers
Validated agents built for controlled manufacturing environments
Batch monitoring and release
Monitor CPPs, flag OOS results, generate batch summaries.
ROI
Process
Monitor CPPs in real time
Temperature, pressure, pH, and flow data from reactors and process equipment streamed continuously
Flag OOS results
AI compares parameters against specification limits and flags deviations requiring investigation
Generate batch summaries
Structured batch record summaries compiled for QP review and release decision
Sources
Originally published: AWS Case Study — Pfizer; Azure Case Study — Roche — reproduced for illustrative purposes
Deviation and CAPA management
Classify deviations, suggest root causes, draft CAPA docs.
ROI
Process
Classify deviations
AI assesses deviation severity by cross-referencing historical events and batch context
Suggest root causes
Pattern matching against past deviations identifies likely root causes and contributing factors
Draft CAPA documents
CAPA documentation drafted for quality team review, with supporting evidence attached
Sources
Originally published: GCP Case Study — Novartis; Azure Case Study — GSK — reproduced for illustrative purposes
QC lab automation
Process LIMS results, flag anomalies, escalate for review.
ROI
Process
Process LIMS results
Test results from analytical instruments ingested automatically via LIMS integration
Detect trends and anomalies
AI identifies out-of-trend results, batch-to-batch drift, and specification boundary risks
Escalate for review
Results requiring scientific judgement escalated with trend context and recommended actions
Sources
Originally published: AWS Case Study — AstraZeneca; Azure Case Study — Merck — reproduced for illustrative purposes
Regulatory document preparation
Structure CTD dossiers and flag issues before FDA/EMA filing.
ROI
Process
Structure dossier content
AI organises study data, CMC sections, and clinical narratives into CTD format
Cross-check consistency
Automated checks identify inconsistencies, missing references, and format deviations
Prepare for submission
Flagged issues resolved, final dossier assembled for regulatory affairs review
Sources
Originally published: GCP Case Study — Roche; Azure Case Study — Pfizer — reproduced for illustrative purposes
Process analytical technology
Predict product quality from spectroscopic and sensor data.
ROI
Process
Capture spectroscopic data
NIR, Raman, and in-line sensor data collected at critical process points in real time
Predict quality attributes
Multivariate models predict CQAs from process data, enabling real-time release testing
Document and validate
Model predictions logged with validation evidence for QA and regulatory review
Sources
Originally published: AWS Case Study — GSK; Azure Case Study — Novartis — reproduced for illustrative purposes
Supplier and raw material intelligence
Screen supplier quality and flag material risks pre-batch.
ROI
Process
Screen supplier data
CoA trends, audit findings, and quality history aggregated across your approved supplier base
Score material risk
AI ranks incoming materials by risk based on supplier track record and specification trends
Alert before batch impact
High-risk materials flagged for additional testing before they enter the production process
Sources
Originally published: GCP Case Study — J&J; AWS Case Study — AbbVie — reproduced for illustrative purposes
SOP and document control
Find SOP inconsistencies and draft update proposals for QA.
ROI
Process
Analyse SOP corpus
NLP processes your entire SOP library to map cross-references, definitions, and procedures
Detect inconsistencies
AI flags conflicting instructions, outdated references, and gaps against current regulations
Propose updates
Draft revisions generated with tracked changes for QA review and document control approval
Sources
Originally published: Azure Case Study — Merck; GCP Case Study — Roche — reproduced for illustrative purposes
Pharmacovigilance and signal detection
Process adverse events and draft ICSRs with human oversight.
ROI
Process
Ingest AE reports
Adverse event data from clinical trials, spontaneous reports, and literature collected automatically
Classify signal severity
AI scores signal strength, classifies causality, and prioritises cases for medical review
Draft ICSRs
Individual case safety reports drafted with human-in-the-loop review before regulatory filing
Sources
Originally published: AWS Case Study — AstraZeneca; Azure Case Study — Novartis — reproduced for illustrative purposes
GMP validation documentation
IQ/OQ/PQ documentation and change control delivered built-in.
ROI
Process
Generate IQ/OQ/PQ protocols
Installation, operational, and performance qualification documents created during deployment
Execute and document
Validation testing performed with evidence captured in GMP-compliant format
Establish periodic review
Change control procedures and scheduled revalidation protocols handed to your QA team
Sources
Originally published: GCP Case Study — Pfizer; AWS Case Study — GSK — reproduced for illustrative purposes
Vice President, Digital Innovation, AstraZeneca
Puja Iyer
"By integrating AI into our drug design and optimisation workflows on Microsoft Azure, we have achieved more than 50 percent faster progression from target identification to candidate selection. That is compressing years of traditional research into months — and doing it with the scientific rigour our regulatory submissions demand"
Originally published: Microsoft Customer Stories — AstraZeneca — reproduced for illustrative purposes
How we work in GMP environments
We do not treat GMP compliance as a checkbox after delivery. We map every AI system to your validation requirements, write URS and functional specifications before we build, and deliver IQ/OQ/PQ documentation as part of the engagement.
Every agent runs on your cloud tenant. Your batch data, your LIMS data, your patient data — none of it leaves your environment. Your QP can inspect it. Your FDA investigator can audit it.
01
GMP risk assessment
We classify your AI use case against GxP impact categories and define the validation approach before any build begins.
02
30-day proof of concept
A validated AI agent on your cloud, integrated with your controlled systems, with validation documentation from day one.
03
Validation by design
IQ/OQ/PQ packages, change control procedures, and periodic review protocols delivered alongside the working system.
04
Scale in 12–18 weeks
From one validated workflow to measurable manufacturing efficiency gains — with a compliance record your QP owns.
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Frequently Asked Questions
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